Drug product
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
D-0763-2023
Product summary
- Event
- Event 92376
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,249,980 vials
- Official record key
drug-enforcement:D-0763-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: NFL101, NFL102, EXP: 1/31/2024; Lots: NFL103, NFL104, EXP: 5/31/2024; Lot: NFL201, EXP: 03/31/2025; Lot: NFL202, EXP: 5/31/2025;
Distribution pattern: Nationwide USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility